Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000408886
Ethics application status
Approved
Date submitted
9/04/2012
Date registered
12/04/2012
Date last updated
12/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
comparison of benefit of tramadol-only treatment and tramadol+gabapentin treatment in patient with lumbar disc herniation after epidural steroid injection
Scientific title
a clinical trial to compare the effect of tramadol only treatment with tramadol + gabapentin treatment on the clinical course, serotonin level, and inflammatory response for patients with lumbar disc herniation after epidural steroid injection
Secondary ID [1] 280284 0
Nil
Universal Trial Number (UTN)
u1111-1129-8263
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar disc herniation 286263 0
Condition category
Condition code
Musculoskeletal 286457 286457 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the patients received a single dose steroid and local anesthesia mixture epidurally via the lumbar approach In study group (Group T, (Tramadol, n=20). Injection dose was adjusted to 10 ml from triamcinolone acetonide, and 0.125% bupivacaine mixture. Oral dose of 100 mg/day tramadol was added to the treatment of patients in group T during study period (15 days).
Intervention code [1] 284637 0
Treatment: Drugs
Comparator / control treatment
All the patients received a single dose steroid and local anesthesia mixture epidurally via the lumbar approach In comparator group (Group TG, (Tramadol+Gabapentin, n=20). Injection dose was adjusted to 10 ml from triamcinolone acetonide, and 0.125% bupivacaine mixture. Oral dose of 100 mg/day tramadol + 1800 mg/day gabapentin was added to the treatment of patients in group TG during study period (15 days).
Control group
Active

Outcomes
Primary outcome [1] 286911 0
Clinical improvement as asssesed by Visual Analogous Scale (VAS), Oswestry Disability Index (ODI) and Straigt Leg Elevation Test (SLET).
Timepoint [1] 286911 0
at 15 days after starting to use drugs
Secondary outcome [1] 296975 0
Inflammatory response as assesed by Leucocyte (WBC), erythrocyte sedimentation rate (ESR), C Reactive Protein (CRP) and urine serotonin levels.
Timepoint [1] 296975 0
at 15 days after starting to use drugs

Eligibility
Key inclusion criteria
Herniated lumbar disc, epidural steroid injection
Minimum age
20 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
bilateral root pressure findings, neurologic deficit, previous lumbar vertebral surgery history, serious cardiac, pulmonary, hematological, gastrointestinal, and liver or kidney disease, glaucoma, urinary retention, statin group drug usage, hormone replacement therapy, and known allergy to the study drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4244 0
Turkey
State/province [1] 4244 0

Funding & Sponsors
Funding source category [1] 285058 0
Self funded/Unfunded
Name [1] 285058 0
Country [1] 285058 0
Primary sponsor type
Individual
Name
Mustafa ISIK
Address
University of Gaziantep, Faculty of Medicine, Orthopedic department. Universite bulvari Sahinbey Hastanesi Ortopedi Klinigi. 27100 / Gaziantep
Country
Turkey
Secondary sponsor category [1] 283922 0
None
Name [1] 283922 0
Address [1] 283922 0
Country [1] 283922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287063 0
Ethics Committee of University of Gaziantep / Turkey
Ethics committee address [1] 287063 0
Ethics committee country [1] 287063 0
Turkey
Date submitted for ethics approval [1] 287063 0
Approval date [1] 287063 0
Ethics approval number [1] 287063 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34031 0
Address 34031 0
Country 34031 0
Phone 34031 0
Fax 34031 0
Email 34031 0
Contact person for public queries
Name 17278 0
Mustafa ISIK
Address 17278 0
University of Gaziantep, Faculty of Medicine, Departmant of Orthopedic.

Gaziantep Universitesi Tip Fakultesi Ortopedi ve Travmatoloji A.D. 27100 / Gaziantep / Turkiye
Country 17278 0
Turkey
Phone 17278 0
+90 533 6361796
Fax 17278 0
Email 17278 0
[email protected]
Contact person for scientific queries
Name 8206 0
Mustafa ISIK
Address 8206 0
University of Gaziantep, Faculty of Medicine, Departmant of Orthopedic.

Gaziantep Universitesi Tip Fakultesi Ortopedi ve Travmatoloji A.D. 27100 / Gaziantep / Turkiye
Country 8206 0
Turkey
Phone 8206 0
+90 533 6361796
Fax 8206 0
Email 8206 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.